VETERINARY SERVICES MEMORANDUM NO. 800.115 

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Potency and Safety Testing by Unlicensed Facilities

I. PURPOSE

This memorandum provides guidance to licensees, permittees, and applicants for engaging 

unlicensed facilities to conduct potency and safety testing of biological products. 

II. REPLACEMENT

This memorandum replaces Veterinary Services (VS) Memorandum No. 800.115 dated 

June 21, 2013. 

III. BACKGROUND

Manufacturers must maintain testing expertise to assess their products properly, as described 

in title 9, Code of Federal Regulations (9 CFR), part 113.5(b). Also, per 9 CFR, part 

114.3(a), licensed establishments must be separate from any other establishments used for 

biological products. Consequently, potency and safety testing of a product by an unlicensed 

facility under contract has not routinely been permitted. 

Methods for potency testing have become increasingly sophisticated, often requiring 

specialized laboratory equipment with specially trained operators. It may be impractical for 

manufacturers to acquire and maintain this equipment and operating expertise, althoughthe 

associated potency methods may be superior to available alternatives. In other circumstances, 

manufacturers may not require animal facilities for any tests other than final product safety 

testing. Thus, the Center for Veterinary Biologics (CVB) considers it permissible and prudent 

to allow manufacturers to contract with unlicensed facilities to perform certain testing under 

specific circumstances. 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service

Veterinary 

Services

Washington, DC 

20250

for
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V. POLICY

The appendix of this memorandum provides guidance for engaging unlicensed facilities to 

perform potency and animal safety testing.

VI. IMPLEMENTATION/APPLICABILITY

This guidance is effective immediately.

Appendix
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Appendix

Guidelines for Implementation of Testing by Unlicensed Facilities

1. Scope of Testing

Manufacturers may contract with unlicensed facilities to perform serial release safety and 

potency testing, but not for other serial release testing. Potency testing by unlicensed 

laboratories is restricted largely to bioanalytical methods. Classical culture and titration 

methods will not be considered unless there is a specialized requirement associated with the 

test. Potency tests which require animals will not be considered without extenuating 

circumstances.

Serial release animal testing by unlicensed contractors is limited to target animal and nontarget animal safety tests when the need to conduct those tests is the only reason the licensed 

establishment maintains animal facilities. 

2. Location of Unlicensed Facility

The facility must be located in the United States, District of Columbia, the Territories, or any 

other place under the regulatory jurisdiction of the United States.

3. Authority to Inspect 

The unlicensed facility must agree to submit to periodic inspections of the facility by CVB. It 

is the responsibility of the licensee to obtain this permission. A letter of consent must be on 

file at CVB. The mail log number of the consent letter must be documented in section V of

the Outline of Production for the product being tested.

4. Procedure to Obtain CVB Approval of Testing by Unlicensed Facility

a. Submission requirements. Submit the following information to CVB-Policy, 

Evaluation, and Licensing (CVB-PEL):

1. Proposal. Include the name, address, and phone number of the facility; the 

primary and alternate site contact at the unlicensed facility; and, the type of 

testing performed, by product code.

2. Audit. Licensees must perform an on-site audit of the unlicensed facility, provide 

the audit report and an audit plan to CVB. The audit report must include 

descriptions of the facility, testing capability, quality assurance program, sample 

quarantine, sample tracking system, sample disposal procedure, and qualifications 

of personnel. The audit plan must describe the plan for subsequent audits and 

identify who will perform the audits as part of ongoing quality management at the 

unlicensed facility. If the audit has not been conducted by the time the proposal is
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submitted, it must be submitted and approved before commencing testing at the 

facility. 

3. Authorization to Inspect. Provide a letter from the unlicensed facility authorizing 

Animal Plant and Health Inspection Services (APHIS ) to inspect the facility and 

review all records relevant to the testing of veterinary biologic products. CVB 

may elect to conduct an inspection prior to approving use of the facility.

4. Verification of Test Method Transfer. If the licensee developed and validated the 

test method, then provide a report verifying that the test method has been 

satisfactorily transferred from the licensee to the unlicensed facility. Material 

tested by the licensee and the unlicensed facility should produce equivalent 

results. CVB may also require confirmatory testing. 

If the unlicensed facility developed and validated a potency test method, then 

provide an assay validation report to CVB for review, approval, and possible 

confirmatory testing. This section does not apply to animal safety tests.

5. Outline of Production. Submit a revised Outline of Production containing the 

following information in section V.C:

• Facility name, address.

• Identification of the test.

• Conditions for shipment of product to the testing site, including the number of 

samples per test, volume, mode of transportation, and temperature/packaging 

requirements.

• The mail log number and date of the CVB approval for the contract testing 

(for each test).

• Detailed description of test method or reference to a Special Outline for each 

test.

b. Notification of Approval by CVB. CVB will notify the licensee by letter that testing 

by the unlicensed facility is approved. CVB will reissue the product license with the 

restriction described above and approve the revised Outline of Production.

Once the licensee receives the letter of approval, product license, and updated Outline 

of Production naming the unlicensed facility, the licensee may begin using the 

unlicensed facility for testing.

5. Licensee Responsibilities

Regardless of the site where serial release testing is performed, the licensee retains 

responsibility for ensuring testing is conducted according to the approved Outline of 

Production and for maintaining records as described in 9 CFR, parts 113.5(c), 115.1(a), 

and 116. 
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As described in 9 CFR 113, 114, 115, and 116, the licensee is responsible for compliance 

with the regulations for all steps in the preparation of the product. The licensee must 

maintain records of all written, electronic, and oral communication with the unlicensed 

facility pertaining to testing of prelicense and licensed product. The licensee must have 

procedures for shipping, tracking, and disposing of samples shipped to the unlicensed 

facility.

The licensee must report unsatisfactory test results (per 9 CFR, part 116.5 and VS

Memorandum No. 800.57). Changes in the testing procedure, or changes at the 

unlicensed facility affecting testing, must be submitted for review to CVB-PEL prior to 

implementation of the changes.

6. Unlicensed Facility Responsibilities

The unlicensed facility must provide the licensee with a letter, signed by an officer of the 

facility, indicating the unlicensed facility agrees to inspection under the Virus Serum 

Toxin Act. 

Personnel at the facility must store samples and perform testing according to the 

procedure described in the licensee’s filed Outlines of Production and Special Outlines. 

They must inform the licensee of any proposed changes in testing methodology. These 

changes must be approved by CVB prior to implementation (9 CFR, part 114.8).

Unlicensed facilities must maintain original testing and sample storage records on site 

and have these documents available for inspection by CVB. They should provide exact 

copies of these records to the licensee.

7. Animal facilities

Facilities conducting animal tests must have a functional Animal Care and Use 

Committee and operate in compliance with all applicable animal welfare regulations.

8. Revoking unlicensed facility authorization

If either the licensee and/or the unlicensed facility fails to meet their responsibilities, the 

approval related to the contract testing may be revoked.